FDA.reportPublic FDA data

evonos

Primary DI
04054462902743
Brand
evonos
Company
evonos GmbH & Co. KG
Model
WT152500
Catalog number
WT152500
Device description
Tongue depressor, acc. to Hartmann, size 25 x 150
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04054462902743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04054462902743040544629027434054462902743

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, reusableA hand-held device intended to be used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make it less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342657915
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04054462156481evonosWT119400WT1194002026-08-26
04054462156498evonosWT524820WT5248202026-08-26
04054462156504evonosWT415000WT4150002026-08-26
04054462913039evonosWT415100WT4151002026-08-26
04054462913602evonosWT430432WT4304322026-08-25
04054462913619evonosWT430450WT4304502026-08-25
04054462913626evonosWT430452WT4304522026-08-25
04054462913633evonosWT432000WT4320002026-08-25
04054462913732evonosWT438512WT4385122026-08-25
04054462913763evonosWT438714WT4387142026-08-25
04054462913794evonosWT439000WT4390002026-08-25
04054462913824evonosWT439100WT4391002026-08-25
04054462913831evonosWT439200WT4392002026-08-25
04054462913855evonosWT440500WT4405002026-08-25
04054462913893evonosWT441500WT4415002026-08-25
04054462913909evonosWT442000WT4420002026-08-25
04054462913916evonosWT442100WT4421002026-08-25
04054462913923evonosWT442200WT4422002026-08-25
04054462913947evonosWT444000WT4440002026-08-25
04054462913978evonosWT445000WT4450002026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462902675evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902682evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902750evonosevonos GmbH & Co. KGGAF2026-08-21
04054462917495evonosevonos GmbH & Co. KGGAF2026-08-19
04054462901548evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902699evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902705evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902712evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902729evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902736evonosevonos GmbH & Co. KGGAF2026-08-18
B382SD571001EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571002EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571004EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17
00810158217669PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17